Effect of Intermittent Oro-esophageal Tube vs Nasogastric Tube in Tracheostomized Patients With Intracerebral Hemorrhage

Zeng Changhao

Status: Terminated

Conditions: Intracerebral Hemorrhage

Treatments: Behavioral: comprehensive rehabilitation therapy; Device: Intermittent Oro-esophageal Tube Feeding; Behavioral: Basic treatment; Device: Nasogastric Tube Feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT06203561

2022-KY-0132

Details and patient eligibility

About

This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage transferred to the Department of Rehabilitation Medicine of 4 hospitals in China between January 2023 to June 2023.

The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:

Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.

Participants will be divided into two groups randomly, with different nutritional support respectively.

.

Full description

Safe and efficient enteral nutrition support for tracheostomized patients with intracerebral hemorrhage continues to be a challenge. Nasogastric tube feeding has been the mainstay in China but has a significant risk of adverse events. Intermittent oro-esophageal tube feeding is an established enteral nutrition mode that can be used to replace Nasogastric tube feeding. This study reports the clinical effect of Intermittent oro-esophageal tube feeding vs Nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage receiving basic medical treatment and comprehensive rehabilitation therapy.

However, in the field of intracerebral hemorrhage combined with tracheostomy, research on Intermittent oro-esophageal tube feeding is still relatively limited. Therefore, this study was carried out to explore the clinical effect of Intermittent oro-esophageal tube feeding vs. Nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage, mainly on nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit, and intervention-related adverse events.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• meeting the diagnostic criteria for Intracerebral Hemorrhage.
• with placement of a tracheotomy tube.
• requiring enteral nutrition support.
• age over 18 years.
• able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) .

Exclusion criteria

• combined with tumors in the head, neck, esophagus, or gastrointestinal tract
• an abnormal structure observed in the oral, pharyngeal, nasal regions or esophagus
• with unstable vital signs or severe dysfunction of organs including heart, liver, lungs, or kidneys
• with severe hemorrhagic disease or bleeding tendency; 5) with contraindications for enteral nutrition
• with dysphagia caused by non-stroke-related reasons in the past

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

118 participants in 2 patient groups

The observation group

Experimental group

Description:

The patients were provided with 1) basic treatment including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control, and 2) comprehensive rehabilitation therapy including respiratory tract management, care for tracheotomy tube, comprehensive training for hemiplegic limbs, swallowing function training, pulmonary function training, and acupuncture. For the observation group, the nasogastric tube was removed, and Intermittent oro-esophageal tube feeding was initiated for nutrition support within 4 hours after completing the admission assessment, following the standard Intermittent oro-esophageal tube feeding procedure.

Treatment:

Behavioral: comprehensive rehabilitation therapy

Behavioral: Basic treatment

Device: Intermittent Oro-esophageal Tube Feeding

The control group

Active Comparator group

Description:

The patients were provided with 1) basic treatment including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control, and 2) comprehensive rehabilitation therapy including respiratory tract management, care for tracheotomy tube, comprehensive training for hemiplegic limbs, swallowing function training, pulmonary function training, and acupuncture. Patients in the control group were provided with nutrition support by the indwelling nasogastric tube. The entire feeding process strictly followed the standardized procedure for nasogastric feeding.

Treatment:

Behavioral: comprehensive rehabilitation therapy

Behavioral: Basic treatment

Device: Nasogastric Tube Feeding